BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PICC SET: 2-LUMEN 5 FR X 19-1/2" (50 CM)

    MDR report key: 14162170 · Received April 20, 2022

    Report

    Report Number
    9680794-2022-00244
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 24, 2022
    Report Date
    March 29, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    LJS
    PMA / PMN Number
    K042126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    QN# (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: THE NURSE ADVANCED THE SPRING WIRE GUIDE AND CONTINUES WITH DILATOR AND THE PROCESS, BUT THEN TAKING OUT THE SPRING WIRE GUIDE THIS SHOWS SOME RESISTANCE AND THEY HAVE TO USE ULTRASOUND TO VERIFY GUIDE POSITION. FINALLY THEY COULD TAKE IT OUT "WITH A LOT OF DIFFICULTIES". THE SPRING WIRE GUIDE IS REMOVED, BUT ONCE IT IS OUT OF THE PATIENT'S ARM, IT BREAKS IN THE HANDS OF THE NURSE AND PHYSICIAN. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS FINE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: THE NURSE ADVANCED THE SPRING WIRE GUIDE AND CONTINUES WITH DILATOR AND THE PROCESS, BUT THEN TAKING OUT THE SPRING WIRE GUIDE THIS SHOWS SOME RESISTANCE AND THEY HAVE TO USE ULTRASOUND TO VERIFY GUIDE POSITION. FINALLY THEY COULD TAKE IT OUT "WITH A LOT OF DIFFICULTIES". THE SPRING WIRE GUIDE IS REMOVED, BUT ONCE IT IS OUT OF THE PATIENT'S ARM, IT BREAKS IN THE HANDS OF THE NURSE AND PHYSICIAN. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271702 ARROW PICC SET: 2-LUMEN 5 FR X 19-1/2" (50 CM) CATHETER, INTRAVASCULAR, THER LJS ARROW INTERNATIONAL LLC 14F21G0285

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown